Senior Regulatory Affairs Specialist

 — Genève
25.02.2020Mitarbeiter100%

Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

 

In the frame of the growth of our business, we are looking for a:

 

Senior Regulatory Affairs Specialist

Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

 

In the frame of the growth of our business, we are looking for a:

 

Your tasks :

Under the supervision of the Regulatory Affairs Head, your main tasks will be:

  • This position will be focused on the registration of Class III medical devices in US:

    • Preparation and writing of registration dossiers (ex : PMA and IDE

    • Manage the follow-up of the registration procedures and preparation of responses to FDA question

    • Assist the team in the Regulatory evaluation of US changes (Change control

    • Manage the maintenance of US licences (ex: annual report, supplements)

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments

  • Prepare and support audits conducted by Notified Bodies and Competent Authorities

  • Be the regulatory affairs representative in the varied project teams

  • Key contact and support for distributors

  • Follow-up the regulatory monitoring for medical devices

 

Your profile :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area

  • Be familiar with US FDA regulations

  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)

  • Excellent knowledge of English language

  • Team player and enthusiastic individual, versatile and dynamic

  • Team-oriented personality

  • Ability to work in a dynamic environment

  • A first experience in project management would be a plus

 

 

Rue de Lyon, 105 1203 GENEVE

Info

Info

25.02.2020
Mitarbeiter, 100%
Kontakt
Rue de Lyon, 105 1203 GENEVE

Firma

Branche:Chemie/ Pharma
Offene Stellen:14 Jobs
Standort:Rue de Lyon, 105
1203 GENEVE
Website:http://www.teoxane.com
Salary

Lohncheck

Nutze den Service von jobs.ch und finde heraus, was man als Manager Regulatory Affairs verdient.
Diese Webseite benutzt Cookies, um den bestmöglichen Service zu bieten. Weitere Informationen sind in unserer AGB und in der Datenschutzerklärung zu finden.